PMA P100047S111
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S111
- Product code
- DSQ
- Decision date
- 2018-03-15
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for an elongated HVAD Coring Tool and an elongated HVAD Sewing Ring Wrench.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S111
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-03-15
- Decision code
- APPR
- Date received
- 2017-09-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an elongated HVAD Coring Tool and an elongated HVAD Sewing Ring Wrench.